Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Device: Accu-Chek Combo Kit mg DE/de

• Registration Number: NCT01050868
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Status Verified: 2011-01
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subjects >/= 18 years at screening
• Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit
• Subjects have to use a fast acting analog insulin
• HbA1c = 9% (measured with DCA 2000)
• Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (~10 tests per day) with skipped meals and testmeals
• Willing to use the 3 different bolus calculators during the course of the study
• Willing to undergo planned hyperglycemia
• Willing to perform high frequency BG monitoring (> 20 / day) during the experiment

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Exclusion Criteria

• Type 2 Diabetes
• Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)
• Current addiction to alcohol or substances of abuse
• Pregnant or lactating women
• Any known life-threatening disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Accu-Chek Combo Kit mg DE/de	-

Primary Outcome Measures

Name	Time	Method
To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL.	6 hours after meal

Secondary Outcome Measures

Name	Time	Method
To compare the absolute difference between the SMBG value and the target value between the calculators	6 hours after meal
To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators	6 hours after meal
To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators	6 hours after meal